HK1135049A1 - Insertion device for insertion heads, in particular for infusion sets - Google Patents

Abstract

An insertion device for applying an infusion set to the body of a patient, wherein the device has two actuation members which have to be actuated simultaneously to trigger an insertion movement by which a cannula of the infusion set is introduced into the body and wherein, in some embodiments, one of the actuation members is a securing slide including a contact face to be placed on the body of the patient, the securing slide being actuated by the insertion device being pressed, via the contact face, against the body of the patient.

Description

Insertion tool for an insertion head, in particular for an infusion device

The present invention relates to an insertion tool adapted for an insertion head, an arrangement constituting the insertion tool, the use of the insertion tool or arrangement, and a method for applying an insertion head to a patient's body using an insertion tool according to the preambles of the independent patent claims of the present invention.

In patients (e.g. a particular patient population suffering from pain or patients suffering from type I and type II diabetes) who regularly require a drug (which may be administered by direct infusion into body tissue or the bloodstream), it is advantageous to supply the required amount of drug in liquid form to the body via a cannula which is inserted into the body at a suitable location and which remains at that location for a considerable period of time. For this purpose, a cannula arrangement, which depending on its setting is arranged as an infusion set or port, is fixed to the skin of the patient, the cannula in this way being passed through the skin and into the body.

Furthermore, efforts are made in particular to monitor specific medical parameters of the patient, for example the blood glucose value, over a relatively long period of time. For this purpose, the sensor arrangement is, for example, placed on the patient's body and passed through the skin and into the patient's body with the piercing tip of a suitable sensor.

To avoid infection, infusion sets, ports, or sensor configurations must be replaced periodically (e.g., every three days). In the treatment of, for example, an outpatient with diabetes, this is typically done by the patient himself, and because the infusion cannula or puncture tip is inserted into the skin, there is a certain degree of pain associated with the insertion. It is therefore important that such infusion sets, ports or sensor arrangements are easily and safely applicable, which is why some manufacturers have at the same time begun to arrange their products as insertion heads adapted to the particular insertion tool, by means of which these insertion heads can be applied to the body of a patient. In this way, application is made easier and the pain caused by application is minimized due to the rapid and targeted puncturing process.

Thus, for example US6,607,509B2 discloses an insertion device for an infusion set, wherein the infusion set is abruptly placed onto the administration site by the force of a pre-tensioned spring and the cannula penetrates the patient tissue. In this case, the insertion tool is triggered by actuating a trigger button (provided at one end and lockable and unlockable by rotating it) or by simultaneously actuating two radial trigger buttons located opposite each other.

WO03/026728a1 discloses a similar insertion tool which is triggered by pressing together two retaining arms with locking lugs or by pressing a trigger button.

WO2004/110527a1 also discloses a similar insertion tool for infusion devices, wherein triggering takes place by actuating a single trigger button which is provided at one end and which can be alternately locked and unlocked by pivoting a safety lever or by simultaneously actuating two trigger buttons located opposite each other.

However, all these known insertion devices have the disadvantage that they are not safe or not safe enough to prevent inadvertent triggering, since any safety means (any safety means that are actually present at present) cannot be properly triggered or are always ineffective before placing them on the application site. There is therefore a considerable risk that the user accidentally triggers the insertion device and gets injured, for example from an infusion cannula of a back-up infusion set or from a piercing tip of a back-up sensor arrangement.

It is therefore an object of the present invention to obtain an insertion tool suitable for an insertion head which does not have the drawbacks of the prior art or at least partially overcomes them.

This object is achieved by an insertion tool as described below.

Accordingly, a first aspect of the invention relates to an insertion device suitable for an insertion head, which may be provided, for example, as an infusion set, a port or a sensor arrangement (for example for measuring the blood glucose level), which insertion device has one or more contact surfaces which are formed by a housing of the device and by means of which the insertion device is placed on the skin of a patient in order to apply the insertion head.

The insertion device also comprises a holding device by means of which the spare insertion head can be temporarily held on the insertion device, with the result that the insertion device only needs to be held by the user in the application position during the actual application of the insertion head.

The application-ready insertion device furthermore comprises a drive device by means of which the insertion head prepared for use can be moved relative to the contact surface in the longitudinal direction of the infusion cannula or puncture tip from a first position, in which its infusion cannula or puncture tip is held retracted relative to the contact surface by the holding device in such a way, to a second position, in which the infusion cannula or puncture tip projects substantially completely from the contact surface in order to insert the infusion cannula or puncture tip into the patient when the insertion device is placed with its contact surface on the skin of the patient. This action of inserting the head (by which it is actually applied to the body) is set according to the claims as an inserting action.

The insertion tool further comprises at least two actuation members which must be actuated simultaneously in order to trigger the insertion action. The first actuation member is arranged in such a way as to be actuated by pressing the contact face of the insertion tool (preferably by pressing it in the direction of the insertion motion) against the body of the patient.

This inventive configuration of the insertion tool significantly reduces the risk of accidental triggering of the insertion tool when ready for use, thereby considerably reducing the possibility of injury to the user.

In a preferred embodiment of the insertion tool, the actuating members which have to be actuated simultaneously in order to trigger the insertion action are arranged in such a way that when the actuating force is stopped, they automatically adopt their unactuated state from them. In this way the safety against accidental triggering of the insertion tool can be further increased.

In another preferred embodiment of the insertion tool, the first actuation member is provided as a slide-shaped or button-shaped element, which is preferred if the latter simultaneously forms the entire contact surface or if there are several contact surfaces forming all contact surfaces. The above is advantageous in that it allows the first actuation member to be reliably actuated independently of the application of unknown surface contours on the patient's body.

In yet another preferred embodiment, the at least one further actuation member is configured as a button-shaped element which can be actuated when a user presses it with a fingertip. The actuation direction is preferably transverse (in particular perpendicular) to the direction in which the insertion tool is pressed onto the patient's body, which is preferably the same as the direction of the insertion movement described, and thus the same as the insertion direction of the infusion cannula or puncture tip. In this way the risk of accidental actuation of the actuation member with said first actuation member is further reduced, which further reduces the risk of accidental triggering of the insertion tool.

In some embodiments it is also advantageous if the actuation direction is parallel or substantially parallel to the pressing direction.

In yet another preferred embodiment of the invention, all actuating members (which must be actuated simultaneously in order to trigger the insertion action) are configured in such a way that all actuating members can be actuated by one hand of the user. This allows one-handed operation of the insertion tool, so that the insertion tool can be applied by the patient to body parts, such as the buttocks, which are not even reachable with two hands or which are difficult to reach with two hands.

If the drive means of the insertion tool comprise one or more energy storing elements, such as helical, leg or leaf springs made of metal, or rubber spring elements, in order to provide the drive energy for the insertion action, the insertion tool can be applied at any time and at any location independently of an external energy source and can be manufactured relatively inexpensively.

It is advantageous here if the insertion device is configured in such a way that the (preferably repeatable) energy-storing element can be pretensioned by the user and brought into the pretensioned state, so that the insertion device can be brought into the pretensioned state directly before application, is ready for application and can furthermore advantageously be applied several times.

The drive means advantageously comprise a push element for transmitting the drive energy to the insertion head ready for use, and are arranged in such a way that the energy-storing element can be pretensioned by moving the push element in a direction opposite to the insertion action and by subsequently locking the push element (which can be released by the actuating member) with the locking means, so that the energy-storing element can be brought into a pretensioned state. In this way, a reliable drive means may be provided which allows a high initial acceleration and thus a fast insertion movement, as a result of which the pain of administration caused by inserting the infusion cannula or the puncture tip into the body may be minimized.

A simple and reliable pretensioning mechanism can be achieved if the pushing element of the energy-storing element is advantageously rigidly connected to a gripping part which can be gripped by hand and moved relative to the housing in order to pretension the energy-storing element.

Alternatively, it is also preferred if the insertion device is arranged in such a way that it comprises a housing with two housing parts which can be pushed together and which can be coupled to the push member in such a way that by pushing the two housing parts together the latter can be moved, preferably displaced, in order to pretension the energy-storing element. This setup variant is particularly user friendly.

In yet another preferred embodiment of the insertion tool according to the invention, its actuating members, which are actuated in order to trigger the insertion action, are coupled to each other in such a way that by actuating one of these actuating members, the stopping of another or several others of these actuating members can be cancelled. In this way, the construction can be simplified, since only a single triggering mechanism is required.

In an embodiment comprising a housing having two housing parts which can be pushed together and which can be pushed together to pretension the energy-storing element, it is preferred that the two housing parts can be pulled apart from each other again after the energy-storing element has been pretensioned, and they are arranged in such a way that one of the two housing parts is coupled to a locking device with which one or several actuating members of the insertion tool can be stopped. The coupling is effected in such a way that the stop can be cancelled by renewing and at least partly pushing the two housing parts together. After coupling to the locking means, the housing parts thus coupled form the actuating member of the insertion tool. This arrangement provides the advantage that the insertion device is only activated after the two housing parts have been deliberately pulled apart again, so that the safety against accidental activation of the insertion device is further increased.

If the pushing element, the positioning means and the housing part connected or connectable to these are arranged in such a way that the coupling between the positioning means and the housing part can be cancelled again after the insertion action has been triggered by the pushing element, which is preferably the case, then the insertion tool returns to its original state after the insertion head has been correctly applied. Renewed triggering is only possible after the energy-storing element has been pretensioned again by pushing the housing parts together and subsequently pulling them apart again, wherein one of the housing parts can be coupled to the locking device.

In a further preferred embodiment of the insertion tool according to the invention, the direction of the insertion movement of the insertion head is perpendicular to the plane formed by the contact surface or surfaces of the insertion tool.

In an alternative embodiment, the direction of the insertion movement of the insertion head is not perpendicular to the plane formed by the contact face or faces of the insertion tool, but in particular forms an angle of 20 to 45 degrees with said plane.

Depending on the particular application, one or the other of these embodiments may be more advantageous.

A second aspect of the invention relates to an arrangement comprising an insertion device according to the first aspect of the invention and an insertion head, and the insertion head is accommodated or can be accommodated in the latter (i.e. insertion device) and is preferably provided as an infusion set, port or sensor arrangement. Such an arrangement according to the invention is necessarily obtained by fixing a suitable insertion head for application in the inventive insertion tool according to the first aspect of the invention. In addition to the marketing of the inventive and reusable insertion device according to the first aspect of the invention and of the associated insertion head (such as the associated infusion set, port or sensor arrangement), which is joined together by the user shortly before application to form the arrangement according to the invention, it is also proposed that the arrangement according to the preamble of the invention can be used as a disposable article, in which the insertion device can be discarded after application of the insertion head.

A third aspect of the invention relates to the use of an insertion device or arrangement according to the previous aspect of the invention for applying an insertion head to a patient's body, preferably an insertion head arranged as an infusion set, port or sensor arrangement. The above applies and offers obvious advantages for the invention according to the invention.

A fourth aspect of the invention relates to a method for applying an insertion head to the body of a patient, preferably arranged as an infusion set, port or sensor arrangement, using an insertion device according to the first aspect of the invention. In a first step of the method, the insertion tool is provided with an insertion head, which is held in said first position by the holding means. In other words, the inventive arrangement according to the second aspect is made to have the insertion head arranged in said first position. In this way, in a second step, the arrangement is set in such a way that the contact face of the insertion device at the desired application site is located on the body of the patient, so that the infusion cannula or puncture tip of the insertion head can be inserted precisely into the body after a subsequent insertion movement, pressed in such a way that the first actuating member is actuated. In this state, the second and, in addition, any further actuation members provided for triggering the insertion tool (if present) are actuated, thereby triggering the insertion action.

By this method of applying an insertion head to the body of a patient by means of an insertion tool, the risk of injury to the patient by accidentally triggering the insertion tool can be significantly reduced.

In a preferred embodiment of the method, the setting and pressing of the insertion tool and the actuation of the second actuation member and, in addition, any further actuation members (if present) are done with one hand, so that the insertion head can be applied to body parts that are not or are difficult to reach with both hands without the aid of a further person for the patient.

In a further preferred embodiment of the method, the insertion device is pressed in the direction of the insertion movement onto the desired application site on the body of the patient. This makes the application process particularly reliable.

In yet another preferred embodiment of the method, each of the second actuation member and, in addition, any further actuation member (if present) is actuated by the user pressing them with a fingertip in a direction, which is preferably transverse to the direction in which the insertion device is pressed onto the patient's body, thereby further reducing the risk of incorrect triggering of the insertion device.

In certain embodiments of the method, it is furthermore advantageous if the actuation direction is parallel or substantially parallel to the pressing direction.

Further preferred embodiments of the invention are described in the dependent claims and in the subsequent description with reference to the drawings, in which:

fig. 1 shows a vertical section through a first insertion tool according to the invention adapted to an insertion head, in a non-pretensioned state and without an insertion head;

FIG. 2 shows a view of the first insertion tool of FIG. 1 with an insertion head disposed therein in accordance with the present invention;

fig. 3 shows a vertical section through a first insertion tool according to the invention in a pretensioned state, wherein the insertion head is arranged in a fixed state therein;

FIG. 4 shows a view of the first insertion tool of FIG. 3, but in a relaxed state, in accordance with the present invention;

FIG. 5 shows a view of the first insertion tool shown in FIG. 4, but with a trigger button actuated at the moment of triggering, in accordance with the present invention;

FIG. 6 shows a partial vertical section through a second insertion tool according to the invention adapted to an insertion head, in a non-pretensioned state and without an insertion head;

FIG. 7 shows a view of the second insertion tool shown in FIG. 6, but in a pre-tensioned, secured state, in accordance with the present invention;

fig. 8 shows a view of the second insertion device according to the invention shown in fig. 7, but with an insertion head provided therein, which is provided as an infusion set, with the infusion sleeve folded inwards;

FIG. 9 shows a view of the second insertion tool of FIG. 8 but with the infusion sleeve folded outwardly in accordance with the present invention;

FIG. 10 shows a perspective view in partial vertical section of the second insertion tool of FIG. 9 in accordance with the present invention;

FIG. 11 shows a view of the second insertion tool of FIG. 9 in a relaxed state when placed and pressed onto a patient's body in accordance with the present invention;

FIG. 12 shows a view of the second insertion tool shown in FIG. 11 just after application of the insertion head to the patient's body in accordance with the present invention;

FIG. 13 illustrates the view of the second insertion tool of FIG. 12 after removal from the patient's body, in accordance with the present invention;

FIG. 14 shows a partial vertical section through a third insertion tool according to the invention adapted for an insertion head, in a pre-tensioned and secured state and without an insertion head;

FIG. 15 shows a view of the third insertion tool of FIG. 14 in a relaxed state when placed and pressed onto a patient's body in accordance with the present invention;

fig. 16 shows a vertical section through a fourth insertion tool according to the invention in the pretensioned state, with an insertion head arranged therein in the secured state;

fig. 17 shows a vertical section through a fifth insertion tool according to the invention in the pretensioned state, with an insertion head arranged therein in the secured state; and

fig. 18 shows a vertical section through a sixth insertion tool according to the invention in the pretensioned state, with an insertion head arranged therein in the secured state.

A first insertion tool according to the invention adapted for an insertion head is shown in fig. 1 to 5 in different states as they appear in their intended application.

As can be seen from fig. 1 and 2, fig. 1 shows an insertion tool without an insertion head (fig. 1), and then fig. 2 shows an insertion tool with a fixed insertion head (fig. 2), which is in an inactive basic state, comprising a housing 1, a piston-like pushing element 4 arranged displaceably in the housing 1, and an energy storage element arranged as a helical spring 3 for driving the pushing element 4. Below this, the pushing element 4 has a receiving space 12 (see fig. 1) for the force-fixed attachment of an insertion head, which is applied together with the insertion tool and which in this example is provided in fig. 2 as an infusion set 2 (see fig. 2), which receiving space 12 forms said holding means. Since the infusion set 2 is arranged inside the housing 1 in fig. 2, the infusion cannula 5 (not visible here) is protected by the needle guard 14, so that in this state the user is safely protected from injury by the cannula 5. On its top face, the push element 4 has a gripping part 9, by means of which the push element 4 can be pulled upwards relative to the housing 1 against the spring force of the helical spring 3 in order to pretension the helical spring 3. The insertion tool further comprises said first actuation member arranged to position the slide 7 and further comprises two further said actuation members arranged to trigger the buttons 6a, 6b, in the state shown the actuation of the trigger buttons 6a, 6b being stopped by the positioning slide 7. On its top face, the positioning slide 7 is spring-loaded in the downward direction by a return spring 13 in the force-receiving direction. Below it, it has a circular contact surface 10, by means of which circular contact surface 10 the insertion device is placed and pressed onto the body 11 of the patient after application of the infusion set 2.

If the insertion device of fig. 2 is now ready for use and in a pre-tensioned state in order to apply the infusion set 2 accommodated therein, as shown in fig. 3, the release liner of the adhesive plaster 18 is removed and the gripping means 9 is pulled upwards, so that the push element 4 is moved upwards relative to the housing 1 against the force of the spring 3 until the two locking shoulders 8 formed by the push element 4 snap over the locking lugs 15 formed on the two resilient arms 16, which two resilient arms 16 are integral with the housing 1. In this way, the helical spring 3 and the pushing element 4 are now in the pretensioned state and the infusion set 2 is in the first position, in which the infusion cannula 5 is arranged in the housing 1 in a retracted position relative to the contact surface 10. The cannula guard 14 is now removed from the infusion cannula 5 so that the arrangement consisting of the insertion device and the infusion set arranged therein is ready for use. As can be seen, it is still not possible to cause a radially inward actuation movement of the two trigger buttons 6a, 6b by the positioning slide 7.

To apply the infusion set 2, the insertion device is now pressed, the contact face 10 is pressed onto the application site on the body 11 of the patient, in this way the positioning slide 7 is slid into the housing 1 against the force of the return spring 13 and, after this has been done, two openings 17 are formed therein which are aligned with the trigger buttons 6a, 6b, the two trigger buttons 6a, 6b can now be moved radially inwards through the openings 17 until the resilient arms 16 are reached. In this state, which is shown in fig. 4, the stopping of the trigger buttons 6a, 6b is cancelled.

Now, in order to trigger the insertion movement of the infusion set 2, the infusion set 2 is driven downwards by the force of the spring 3 starting from the first position shown in fig. 3 and 4, such that the infusion cannula 5 is inserted into the body 11 of the patient, the two trigger buttons 6a, 6b are pressed radially inwards, bringing the resilient arms 16 with them, until the locking lugs 15 of the resilient arms 16 disengage from the locking shoulders 8 of the pushing element 4, and the pushing element 4 and the infusion set 2 contained therein are ejected downwards by the drive of the force of the spring 3. Fig. 5 shows a starting state of the insertion operation.

As will be seen, the infusion device 2 has a fixing plaster 18 on its underside. When applied to the patient's skin in this manner, which secures it, the infusion set 2 detaches itself from the receiving space 12 in the pushing element 4 and remains in the application position on the patient's body 11 when the insertion device is subsequently lifted from the patient's body 11.

When the trigger buttons 6a, 6b are released again after the insertion tool has been lifted from the patient's body 11, they are moved radially outwards again, driven by a return spring (not shown). The positioning slide 5 is then driven back by the return spring 13 into its positioning position shown in fig. 1 to 3. The insertion device is now once again in the state shown in fig. 1 and can be applied again for applying the infusion set 2.

A second insertion tool according to the invention is shown in partial vertical section in fig. 6 to 13 in different states which occur in its intended application, and fig. 10 is a perspective view of the insertion tool shown in partial vertical section.

As can be seen from fig. 6 and 7, which show an insertion tool without an insertion head, fig. 6 shows the insertion tool in a non-pretensioned state on the one hand, and fig. 7 shows the insertion tool in a pretensioned state on the other hand, which insertion tool comprises a housing which is formed by two housing parts 1a, 1b which can be pushed together, the push element 4 being mounted in the upper housing part 1b in such a way that it is vertically displaced by a pair (two) of mechanically synchronized pivot levers 19a, 19b, and said energy-storing element being formed as a torsion spring or leg spring 3 and engaging on a respective pivot lever of the pair 19a, 19b of pivot levers for driving the push element 4 forward. As can be seen from fig. 7, in which the pushing element 4 is arranged in an upper housing part 1b, wherein this housing part 1b has a pretensioned torsion spring 3, said housing part 1b comprises two opposing spring clips 12 (only one of which is visible), which spring clips 12 are fixed to the housing and function as said retaining means, between which the infusion set 2 can be retained by clamping. In this case, the infusion set 2 is therefore held in the upper housing part 1b and is immovable relative to the pushing element 4 in comparison with the previously described first exemplary embodiment. As can be seen from fig. 6, the push element 4 here has two cantilevers 20a, 20b on the support surface of the lower housing part 1a, so that when the two housing halves 1a, 1b are pushed together from the starting position shown in fig. 6, they are pushed into the upper housing part 1b against the force of the torsion spring 3 and the locking lug 15 of the spring arm 16 arranged on their top surface engages with the locking shoulder 8 in the upper housing part 1 b. In this state, as shown in fig. 7, the torsion spring 3 and the urging element 4 driven by the torsion spring 3 are in a pretensioned state.

A suitable infusion set 2 may now be mounted into the insertion instrument and clamped by sandwiching it between two resilient cards 12. This state is shown in fig. 8.

As can be seen from a comparison of fig. 9 and 10, fig. 9 and 10 show the insertion device according to fig. 8 with the infusion set 2 ready for use, with the two housing parts 1a, 1b subsequently pulled apart, the infusion set 2 according to the invention comprising an outwardly foldable infusion sleeve 5. As can be seen from fig. 8, the infusion cannula 5 is arranged hidden inside the two-part housing of the infusion set 2 after insertion of the infusion set 2 into the pre-tensioned insertion device. If the two housing parts 1a, 1b of the insertion device are pulled apart starting from the position shown in fig. 8, the two-part housing of the infusion set 2 is pushed together and the infusion cannula 5 is folded outwards by the internal mechanism. This state is shown in fig. 9 and 10, in which the infusion set 2 is in the first position. The two-part housing of the infusion set 2 is pushed together by displacing the inclined surface 21 on the lower housing part 1a vertically relative to the horizontally displaceable engagement element 22, which is connected by a left-hand part to the two-part housing of the infusion set 2, as a result of which the left-hand part of the two-part housing is pushed into a right-hand housing part of the latter (the two-part housing of the infusion set 2).

As can be seen from a comparison of fig. 8, 9 and 10, during the aforementioned pulling apart of the two housing parts 1a, 1b of the insertion device, after pretensioning of the latter, i.e. the housing 1b, the inner locking slide 23 is coupled to the lower housing part 1a by means of a locking lug 24, which locking lug 24 is formed by a resilient arm 25 on the locking slide 23 and is arranged vertically displaceably in the lower housing part 1a in a vertical guide groove 26, engaging with a locking shoulder 27 of the lower housing part 1 a. In its position shown in fig. 6 to 10, the locking slide 23 stops the actuation of the actuating member provided as the trigger button 6 on the insertion tool, which is not possible to move in the actuation direction due to the positioning shoulder 29 of the locking slide 23 for the guide ram 28 (rigidly connected to the trigger button 6).

By the above-described arrangement of the locking slide 23 and the lower housing part 1a of the insertion tool, it is now possible, by updating and pushing together the two housing parts 1a, 1b of the insertion tool, to displace the locking slide 23 relative to the upper housing part 1b in such a way that the positioning shoulder 29 frees the guide ram 28 for displacement in the actuating direction of the trigger button 6, thus cancelling the stopping of the trigger button 6. Due to the fact that the locking slide 23 only has a relatively small displacement of the advancing means, it simultaneously ensures in this state that the two housing parts 1a, 1b cannot be pushed together so far, so that the infusion cannula 5 projects beyond the contact surface 10, which would lead to a risk of puncture. In the state shown in fig. 11, where the two housing parts 1a, 1b are pushed together, which allows a displacement of the locking slide 23, whereby a release of the trigger button 6 is obtained by pressing the insertion device onto the patient's body 11 via said contact surface 10 formed on the underside of the lower housing part 1 a. After engagement with the positioning slide 23, the lower housing part 1a thus forms said first actuating member 7.

If the trigger button 6 is pressed in the state shown in fig. 11, the trigger ram 30 presses the locking lug 15 of the pushing device 4 to the left due to the elastic bending of the elastic arm 16; until the locking lug 15 is disengaged from the locking shoulder 8 of the upper housing part 1b and the push element 4 is guided by a pair (two) of pivoting levers 19a, 19b and driven downwards by the force of the pretensioned torsion spring 3. In doing so, the pushing element hits the infusion set 2 (held between the resilient clips 12) under force and ejects it onto the application site, while completing the insertion of the infusion cannula 5 into the patient's body 11, while the fixing adhesive 18 provided on its underside simultaneously fixes it to the patient's skin. This state is shown in fig. 12, in which the infusion set 2 has been detached from the insertion device. If the insertion device is now removed from the patient's body 11 and the actuation of the trigger button 6 is cancelled, the trigger button 6 returns to its unactuated starting position under the action of a return spring 33 (shown only in fig. 6, 9, 11 and 13) and the locking slide 23 returns to its original positioning position by means of the associated return spring 13, since the insertion device is no longer pressed onto the patient's body 11, with the two housing parts 1a, 1b completely pulled apart. At the same time, the locking lug 24 of the locking slide 23 is pressed outwards by the cantilevers 20a, 20b of the push element 4, while the spring arm 25 is elastically bent until the locking lug 24 is disengaged from the locking shoulder of the lower housing part 1 a. This state, in which the insertion tool has just been lifted from the patient's body 11, is shown in fig. 13. The insertion device is now again in the initial state shown in fig. 6, and it can be applied again for applying the infusion set 2.

It should generally be noted that in both the first and second exemplary embodiments, the insertion head of the infusion set 2 is shown provided with a flexible sleeve 5 (soft sleeve), which flexible sleeve 5 is in each case supported by a guide needle 32. After use, these guide needles 32 are removed (not shown here) together with the initially applied infusion set 2 connected to the above-mentioned guide needles 32, and then an infusion line is connected to the remaining used infusion set 2 for the purpose of delivering the infusion liquid into the body 11 of the patient.

Figures 14 and 15 show a third embodiment of an insertion tool according to the invention in partial vertical section, the first in a pre-tensioned and fixed state and the second in a relaxed state when placed and pressed onto the body of a patient. This embodiment corresponds substantially to the second embodiment shown in fig. 6 to 13, except for one difference explained below, and the operating state shown corresponds to that of fig. 9 and 11, except that the insertion head in the insertion tool is not shown here for the sake of simplicity of illustration.

This third embodiment of the insertion tool according to the invention differs essentially from the second embodiment described above in that in this case the actuating button 6 is not stopped by its guide ram 28 (the guide ram 28 is stopped by the locking slide 23), but rather the deflection of the spring arm 16 of the pusher element 4 is cancelled by the engaging element 31 formed on the locking slide 23, as long as the locking slide 23 is in the setting position, so that its locking lug 15 cannot be disengaged from the locking shoulder 8 of the upper housing part 1 b. This state is shown in fig. 14. If, as already described in the preceding example, the locking slide 23 is now caused to displace in the upper housing part 1b by pressing the insertion device onto the patient's body 11 via the contact face 10 of the lower housing part 1a, the engaging element 31 frees the spring arm 16 so that, by pressing the actuating button 6, its locking lug 15 can be disengaged from the locking shoulder 18 in order to trigger the insertion device. All other functions and operation modes are the same as those described in connection with the second exemplary embodiment.

Fig. 16 shows a vertical section through a fourth insertion device according to the invention in the pretensioned state with an infusion set 2 arranged therein in the secured state.

The insertion device of this embodiment differs from the insertion device of fig. 1 to 5 in that it is suitable for use in an inclined application of an infusion set, which is particularly suitable for applications in which the insertion direction of the cannula 5 and the guide needle 32 forms an angle α of less than 90 degrees together with the skin surface at the application site. The angle alpha is preferably in the range of 20 degrees to 45 degrees. In the embodiment shown, it is 45 degrees. For the above, the housing 1 and the positioning slide 7 of the insertion tool shown in fig. 1 to 5 are modified. Another difference is the interface of the pushing device 4 and the infusion set 2, which in the present case is formed by the adapter 34.

All other components and operations of the device are the same as those of the device shown in connection with fig. 1 to 5, so for a detailed description thereof reference is made to the description of fig. 1 to 5.

Fig. 17 shows a vertical section through a fifth insertion device according to the invention in the pretensioned state with an infusion set 2 arranged therein in the secured state.

This insertion tool differs from the insertion tool of fig. 16 in that the infusion set 2 is not attached to the pushing element 4, but is held by an adapter 34 and a frame 35 in the insertion tool housing 1. The adapter 34 is in this embodiment a substantially disc-shaped element with a circumferential groove.

After release and actuation of the trigger buttons 6a, 6b, when the pushing element 4 (with a hammer formed on its surface) is driven downwards under the force of the spring 3, it hits the adapter 34 under the force, so that it is detached from the frame 35 and ejects the adapter 34 together with the infusion set 2 to the administration position, so that the insertion movement of the cannula 5 together with the insertion needle 32 into the body 11 of the patient is completed.

Fig. 18 shows a vertical section through a sixth insertion device according to the invention in the pretensioned state with an infusion set 2 arranged therein in the secured state.

This insertion device differs from the insertion device of fig. 16 in that it is suitable for an infusion set 2 with a tilted cannula 5 and an insertion needle 32, which in the state shown in fig. 18 has been tilted from an inwardly folded state (in which the cannula 5 and the insertion needle 32 are hidden inside the housing of the infusion set 2) to the illustrated outwardly folded state.

As can be seen from the figure, the infusion set 2 is not attached to the push element 4, but is held by a hold-down sleeve 36, which hold-down sleeve 36 holds the infusion set 2 by means of several resilient arms 37. The pushing element 4 is arranged inside a clamping sleeve 36 and the two gripping parts 9 protrude radially through said sleeve 36.

In the loading position (not shown), the clamping sleeve 36 is in the forwardmost position within the housing 1 together with the pushing element 34. After attaching the infusion set 2 to the clamping sleeve 36, the pushing element 4 and the clamping sleeve 36 are retracted by the gripping part 9 until the clamping sleeve 36 engages at the housing 1 with hooks 38 formed at its inner side.

During this movement of the clamping sleeve 36, the two-part housing of the infusion set 2 is pushed together by the inclined surface 21 provided at the inside of the housing 1, whereby the infusion cannula 5 and the insertion needle 32 are folded outwards by the internal mechanism of the infusion set 2.

After release and actuation of the trigger buttons 6a, 6b, when the push element 4 is driven downwards under the force of the spring 3, it expands the resilient arm 37 by contacting a cam element 39 provided at its inner side, thereby releasing the infusion set 2 and hitting the infusion set 2 under force and ejecting it onto the administration site. With this, the insertion operation of inserting the cannula 5 into the patient body 11 together with the insertion needle 32 is completed.

Although the insertion head applied in the above-described exemplary embodiments is not exclusively provided as an infusion set, it should again be explicitly pointed out here that the insertion device shown is also suitable for application with other insertion heads, for example with insertion heads provided as a port or sensor arrangement or as a combination of a sensor arrangement and a port or infusion set, and that the invention is suitable for all available insertion heads which are inserted into a patient by means of a needle-like or blade-like element.

It should also be pointed out here that it is also conceivable to combine the solutions proposed in the different exemplary embodiments, for example an insertion tool according to the first exemplary embodiment shown in fig. 1 to 5, but in which the insertion head is not held by the pushing element, but rather is held separately from the pushing element in the housing, as is the case with the second exemplary embodiment shown in fig. 6 to 13.

Claims (19)

1. Insertion device adapted to receive an insertion head (2), the insertion head (2) having an infusion cannula (5) for insertion into a body (11) of a patient or having a piercing tip, comprising:

a) at least one contact surface (10) for placing the insertion device on an application site on the body (11) of a patient in order to apply the insertion head (2);

b) a holding device (12) by means of which the spare insertion head (2) is temporarily held on the insertion tool; and

c) drive means (3, 4) for moving the insertion head (2) relative to the contact surface (10) in a longitudinal direction of the infusion cannula (5) or the puncture tip from a first position in which the infusion cannula (5) or the puncture tip is retracted relative to the contact surface (10) by holding the insertion head (2) by holding means (12) to a second position in which the infusion cannula (5) or the puncture tip extends substantially completely from the contact surface (10) for allowing introduction of the infusion cannula (5) or the puncture tip into the body (11) of the patient when placing the contact surface (10) of the insertion device onto the body (11) for performing an insertion movement,

the insertion tool further comprises a first (7) and a second (6, 6a, 6b) actuation member which must be actuated simultaneously in order to trigger the insertion action, wherein the first actuation member (7) comprises a slide-or push-button element which is actuated when the contact face (10) of the insertion tool is pressed onto the patient's body (11).

2. The insertion tool according to claim 1, wherein the first and second actuation members (6, 6a, 6b, 7) are arranged in such a way that when the actuation force is stopped, the first and second actuation members (6, 6a, 6b, 7) automatically return to the unactuated state.

3. The insertion tool according to claim 1, wherein the first actuation member (7) forms all contact surfaces (10).

4. The insertion tool according to claim 1, wherein the second actuation member (6, 6a, 6b) is provided as a button-shaped element (6, 6a, 6b), which button-shaped element (6, 6a, 6b) is actuated in a direction transverse to the direction in which the insertion tool is pressed onto the patient's body (11) when the user presses it with a fingertip.

5. The insertion tool according to claim 4, wherein the direction is perpendicular to the direction of pressing the insertion tool onto the patient's body (11).

6. The insertion tool according to claim 1, wherein the first and second actuation members (6, 6a, 6b, 7) are arranged in such a way that the first and second actuation members (6, 6a, 6b, 7) can be actuated with one hand in order to allow a one-handed triggering of the insertion action.

7. The insertion tool according to claim 1, wherein the drive means (3, 4) has at least one energy storage element (3) for providing drive energy for the insertion movement.

8. The insertion tool according to claim 7, wherein the energy storage element (3) is a helical, leg or leaf spring (3) made of metal, or a rubber spring element.

9. The insertion device according to claim 7, wherein the insertion device is arranged in such a way that the energy storage element (3) of the drive (3, 4) can be pretensioned by a user and a ready-to-use pretensioned state can be established.

10. The insertion tool according to claim 9, wherein the drive means (3, 4) comprise a push element (4) for transmitting the drive energy to the insertion head (2) ready for use, and the push element (4) is arranged in such a way that the energy storing element (3) can be pretensioned and is ready for use in the pretensioned state by displacing the push element (4) in the direction relative to the insertion movement and by subsequently locking the push element (4) with the first locking means (8), wherein the first locking means (8) can be released by means of the first and second actuating members (6, 6a, 6b, 7).

11. The insertion tool according to claim 10, wherein the insertion tool comprises a housing (1) and the pushing element (4) is connected to a gripping means (9), which gripping means (9) is graspable by hand and which is movable relative to the housing (1) for pre-tensioning the energy-storing element (3).

12. The insertion tool according to claim 10, wherein the insertion tool comprises a housing (1a, 1b) having two housing parts (1a, 1b), which two housing parts (1a, 1b) can be pushed together and can be coupled to the pushing element (4) in such a way that the latter can be displaced by pushing the two housing parts (1a, 1b) together in order to pretension the energy-storing element (3).

13. The insertion tool according to claim 12, wherein the first and second actuation members (6, 6a, 6b, 7) are operatively connected to each other in such a way that by actuating the first actuation member (7) the stopping of the second actuation member (6a, 6b) can be cancelled.

14. The insertion tool according to claim 13, wherein the two housing parts (1a, 1b) can be pulled away from one another again as a result of the energy storage element (3) being ready for use in the pretensioned state, and in order to form the first actuating member (7), one (1a) of the two housing parts (1a, 1b) is coupled to a second locking device (23), by means of which second locking device (23) the second actuating member (6a, 6b) is arrested, such that by renewed movement the aforementioned arresting is cancelled by pushing the two housing parts (1a, 1b) together.

15. The insertion tool according to claim 14, wherein the pushing element (4), the second locking means (23) and the housing part (1a) connected or connectable to the latter are arranged in such a way that the coupling between the second locking means (23) and the housing part (1a) is cancelled again after the insertion action performed by the pushing element (4).

16. The insertion tool according to claim 1, wherein the direction of the insertion action of the insertion head (2) is perpendicular to the plane formed by the contact face or faces (10) of the insertion tool.

17. The insertion tool according to any one of claims 1 to 15, wherein the direction of the insertion action of the insertion head (2) is not perpendicular to the plane formed by the contact face or faces (10) of the insertion tool.

18. The insertion tool according to claim 17, wherein the direction of the insertion action of the insertion head (2) forms an angle a of 20 to 45 degrees with the plane.

19. An assembly comprising an insertion tool according to any preceding claim and an insertion head (2) housed or receivable in the insertion tool.